The Research Scientist of R&D is responsible for the designing and development various inhaled dosage forms such as solution, suspension, gel, cream, ointment, sterile products etc. This include literature search, pre-formulation studies, prototype development, process scale up and optimization. Responsible to create all the relevant documents and managing of logistics to execute the project in a timely manner.
Essential Functions:
Provide scientific leadership for the development of generic pharmaceutical inhaled dosage forms such as metered dose inhalers, DPI's and sterile solution suspension etc. Design and conduct pre-formulation studies and manufacture lab scale batches to identify prototype.
Provide technical leadership to ensure timely execution of projects starting with the selection of raw materials, packaging components, formulation strategy, scientific development and process scale up. Apply Quality by Design principles in the design of experiments to develop robust formulation and processes.
Write technical reports protocols, batch records and project presentations. Prepare ANDA submission documents such as product formula, manufacturing instructions and product development reports.
Provide creative and scientific solutions to resolve problems while working with complex projects. Analyze the data and propose appropriate action plan.
Work closely with inter-departmental groups and co-ordinates the activities to execute the project in a timely manner to meet the goals.
Delegate the work to junior scientists and supervise them. Provide them necessary training and guidance to overcome any difficulties.
Numbers & Facts
Location
Piscataway, NJ
Skills
Abbreviated New Drug Applicationunmatched
Cross-Functionalunmatched
Data Analysisunmatched
Dosage Formsunmatched
Drug Developmentunmatched
Experiment Designunmatched
Leadershipunmatched
Logistics Managementunmatched
Manufacturingunmatched
Metered Dose Inhalersunmatched
Ointmentsunmatched
Presentation/Verbal Skillsunmatched
Problem Solving Skillsunmatched
Product Developmentunmatched
Product Documentationunmatched
Prototypingunmatched
Reporting Skillsunmatched
Research & Development (R&D)unmatched
Scientific Researchunmatched
Technical Leadershipunmatched
Time Managementunmatched
Training/Teachingunmatched
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